medtronic evolut pro: system overview pro overview .pdf · bav according to standard practice...

Eberhard Grube, MD, FACC, FSCAIUniversity Hospital, Dept of Medicine II, Bonn, GermanyStanford University, Palo Alto, California, USA

Medtronic Evolut Pro:

System Overview

TCTAP 2019Seoul, April 27 -30, 2019

Speaker Bureau/Advisory Board: Medtronic: C, SB, AB, OFLivaNova: C, SB, ABHighlife: AB, SBBoston Scientific: C, SB, ABJena Valve: C,SB, ABCardioMech: C, ABMitral Technology: C, SB,

AB

Equity Interest: InSeal Medical: E, AB, MTEx: E, AB, SBCardiovalve: E, SB, Claret: E, ABShockwave: E, ABValve Medical: E, ABMillipede E, AB, SBPie-Cardia: E, AB, SBImparative Medical: E, ABAncora: E, AB, SB

KeyG – Grant and or Research Support E – Equity Interests S – Salary, AB – Advisory Board

C – Consulting fees, Honoraria R – Royalty Income I – Intellectual Property Rights SB – Speaker’s Bureau O – Ownership OF – Other Financial Benefits‘

Disclosure Eberhard Grube, MD

PROVEN PLATFORM PERFORMANCEMEDTRONIC COREVALVE™ AND EVOLUT™ SYSTEMS

Medtronic CoreValve and Evolut R Systems have an extensive history of proven platform performance:

▪ > 120,000 Implants

▪ > 1,000 Centers

▪ > 100 Countries

3 Medtronic Evolut PRO Overview | Medtronic - Confidential

MEDTRONIC EVOLUT PRO SYSTEMDESIGN GOALS

The Evolut PRO system is a next generation self-expanding transcatheter aortic valve (TAV) that is intended to achieve two primary performance goals:


Provide Advanced Sealing▪ Greater surface area contact▪ Low PVL Rates

Maintain Proven Platform Performance▪ Unsurpassed Hemodynamics▪ Control During Deployment▪ Low Delivery Profile

1

2


MEDTRONIC EVOLUT PRO SYSTEMSYSTEM COMPONENTS

16 Fr Equivalent Delivery System

23/26/29 mm TAVs 23 and 26/29 mm Loading Systems

EVOLUT PLATFORMINDICATED ANNULUS RANGE (MM)

Together, the Evolut PRO and Evolut R Systems treat the widest annulus range of any commercially available TAVR system*


23 mm 26 mm 29 mm 34 mm

Diameter (mm)

Perimeter (mm) †

17** 18 19 20 21 22 23 24 25 26 27 28 29 30

53.4** 56.5 62.8 72.3 81.7 94.2

* Based on CT measurement**Measurement for TAV in SAV only. | † Annulus Perimeter = Annulus Diameter x π

Evolut PRO TAV Evolut R TAV

MEDICAL EDUCATION ACADEMIA

EVOLUT PRO DESIGN GOAL 1: ADVANCED SEALING

EVOLUT PRO TRANSCATHETER VALVE ADVANCED SEALING

Building on Proven Design for Advanced Sealing


Conformable FrameSelf-expanding nitinol frame

conforms to annulus

External WrapExternal wrap increases

surface contact with native anatomy

Consistent Radial ForceFrame oversizing and cell geometry

provide consistent radial force across treatable annulus range

Evolut PROEvolut RCoreValve

EVOLUT PROWRAP DESIGN AND CONSTRUCTION

▪ Evolut R TAV with added external porcine pericardial wrap

▪ Identical frame and inner tissue as Evolut R

▪ External wrap covers first 1½ inflow cells and extended skirt

▪ Sutures secure inner skirt and outer wrap together to the frame

▪ Same number and location of sutures as Evolut R TAV


External Tissue Wrap Increases Surface Contact with Native Anatomy

▪ Surface contact between a transcatheter aortic valve and the native anatomy is critical for effective sealing

▪ Evolut PRO TAV’s conforming frame and consistent radial force provide contact at multiple levels

▪ The external wrap provides added tissue volume between the TAV and native anatomy to help reduce gaps and increase surface contact area

EVOLUT PRO EXTERNAL TISSUE WRAPINCREASED SURFACE CONTACT WITH NATIVE ANATOMY


*Bench top evaluation of the frame contacting the annulus based on a CT analysis of 1 patient; Image Courtesy of Dr. Piazza and Prof. Lange, German Heart Center, Munich GermanyNOTE: Images are for illustrative purposes only and may not be indicative of clinical performance.

Conforming Frame Seals atMultiple Levels*

External Wrap Helps Reduce Gapsto Increase Surface Contact

Bright Green = Contactwith Native Anatomy

PORCINE PERICARDIAL TISSUE INTERACTION

Animal Studies Suggest FavorableResponse and Interaction

with Native Tissue

▪ Low inflammatory response1

▪ Stable and mature tissue growth observed at 90 days post implant1

▪ Thin and even layer of endothelial cells on inner lumen of device


1. Medtronic data on file. 90 day porcine GLP Evolut R study, results may not be indicative of clinical performance2. Medtronic, data on file. 60 day porcine research study model, results may not be indicative of clinical performance.

Evolut PRO explanted from Porcine Model at 60 DaysCross Section between Nodes 1 and 2, example picture from MDT

research study on file illustrating tissue interaction.2


EVOLUT PRO DESIGN GOAL 2: PROVEN PLATFORM PERFORMANCE

EVOLUT PRO SYSTEMPROVEN PLATFORM PERFORMANCE


Evolut R TAV Evolut PRO TAV

Proven Platform Performance

▪ Supra-annular valve function provides unsurpassed hemodynamics

▪ Controlled, accurate deployment with the ability to recapture and reposition

▪ Lowest delivery profile with integrated InLine Sheath

SELF-EXPANDING FRAME▪ Conforms and seals to the annulus

▪ The foundation for recapturability

PROVEN PLATFORM PERFORMANCEEVOLUT FAMILY TAV DESIGN

SUPRA ANNULAR VALVE DESIGN▪ Maximizes leaflet coaptation ▪ Promotes single digit gradients and large EOAs

PORCINE PERICARDIAL TISSUE▪ Thin for low profile delivery

▪ Strength and pliability for durability

Medtronic Evolut PRO Overview | Medtronic - Confidential14

PROVEN PLATFORM PERFORMANCECONTROLLED, ACCURATE DELIVERY WITH ABILITY TO RECAPTURE

EnVeo™ R 16Fr Equivalent DCS enables controlled 1:1 Response

with ability to Recapture


EnVeo R InLine™ Sheath allows treatment of trans-arterial access vessel diameters ≥ 5.5 mm across all Evolut PRO valve sizes

LOWEST DELIVERY PROFILE5.5MM ACCESS VESSEL REQUIREMENT


EVOLUT PRO DELIVERY CATHETER SYSTEMDELIVERY PROFILE COMPARISON

Lowest delivery profile across all valve sizes with InLine Sheath


Evolut R 23/26/29 mm TAV Evolut PRO /Evolut R 34 mm TAV

14 Fr Equivalent 16 Fr Equivalent

Treatable Access Vessel Diameter

20 Fr OD18 Fr OD

≥ 5.0 mm ≥ 5.5 mm

The Evolut System retains its outer diameter as it enters the vessel and remains at this diameter as it is advanced to the annulus.


EVOLUT PRO CLINICAL PERFORMANCE


EVOLUT PRO SYSTEM CLINICAL TRIALPATIENT CHARACTERISTICS

Characteristic, mean ± SD or % N=60

Age, years 83.3 ± 7.2

Female 65.0

BSA, m2 1.8 ± 0.2

STS – PROM, % 6.4 ± 3.9

NYHA Class III or IV 70.0

Peripheral vascular disease 43.3

Atrial fibrillation / atrial flutter 18.6

Diabetes mellitus 43.3

Severe aortic calcification 20.5

LV ejection fraction, % 58.9 ± 12.4

Pre-existing pacemaker 15.0

Forrest, et al., ACC, 2017

EVOLUT PRO SYSTEM CLINICAL TRIALPROCEDURAL OUTCOMES

Characteristic, % or mean ± SD N = 60

General anesthesia 58.3

Iliofemoral access approach 98.3

Valve Size Implanted

26 mm 40.0

29 mm 60.0

Pre-TAVR balloon dilation 51.7

Post-implant balloon dilation 26.7

Percentage of patients repositioned 35.0

Average implant depth, mm 4.3 ± 1.6


EVOLUT PRO SYSTEM CLINICAL TRIALADVANCED SEALING

Low rates of PVL while maintaininglow rates of mortality, stroke, and need for pacemaker


Perc

ent

of

Eval

uab

le E

cho

card

iogr

ams


Mortality 1.7%

Disabling Stroke 1.7%

New PermanentPacemaker

10.0%

30 Day Outcomes

EVOLUT PRO SYSTEM CLINICAL TRIALUNSURPASSED HEMODYNAMIC PERFORMANCE

Supra-annular valve function provides single-digitgradients and large effective orifice areas




EVOLUT PRO CLINICAL TRIALSYMPTOMATIC IMPROVEMENT

87.9% of survivors improved NYHA class at 30 days


MEDICAL EDUCATION ACADEMIAMEDICAL EDUCATION ACADEMIA

EVOLUT PRO TRANSFEMORALPROCEDURE &CASE EXAMPLE


EVOLUT PRO/ EVOLUT R PATIENT SELECTIONAORTIC ROOT CRITERIA

Size 23 mm 26 mm 29 mm 34 mm

Annulus Diameter 17*/18 – 20 mm 20 – 23 mm 23 – 26 mm 26 - 30 mm

Annulus Perimeter (π x Diameter) 53.4*/ 56.5 – 62.8 mm 62.8 – 72.3 mm 72.3 – 81.7 mm 81.7 – 94.2 mm

Sinus of Valsalva Diameter (Mean) ≥ 25 mm ≥ 27 mm ≥ 29 mm ≥ 31 mm

Sinus of Valsalva Height (Mean) ≥ 15 mm ≥ 16 mm

* Measure for TAV in SAV only

Evolut R TAVEvolut PRO TAVValve Size Selection

EVOLUT PRO PROCEDUREPROCEDURE OVERVIEW


Controlled, Accurate Deployment via Familiar Evolut Procedure and Best Practices

Pre-Deployment Deployment Assessment

Vascular Access via 16FR InLine Sheath or 20Fr Introducer

Inspected Loaded Capsule under Fluoro

BAV According to Standard Practice

Advance and Align System within Native Annulus

Align annulus/catheter marker band

Begin Deployment at Target Depth (3 – 5 mm)

Very Slow First 1/3 Deployment

Consider Controlled Pacing(90 – 110 bpm)

Release System Tension Prior to Release

Assess Valve Performance; if PVL ≥ Mild, Wait 10 minutes to

Reassess

Address PVL ≥ Mild According to Standard Practice

Close Vascular Access??

?

EVOLUT PRO CASE EXAMPLEAORTIC ROOT MEASUREMENTS

27 Medtronic Evolut PRO In-service | Medtronic - Confidential


EVOLUT PRO CASE EXAMPLEACCESS MEASUREMENT AND ASSESSMENT


EVOLUT PRO CASE EXAMPLEANNULAR AND LVOT CALCIFICATION ASSESSMENT

EVOLUT PRO CASE EXAMPLESYSTEM TRACKING


EVOLUT PRO CASE EXAMPLEVALVE DEPLOYMENT TO POINT OF NO RECAPTURE


Controlled, 1:1 Response with Ability to Recapture*

*Able to recapture up to three times before reaching the point of no recapture; upon third recapture the system must be removed from the patient and replaced with a new delivery system and TAV.

EVOLUT PRO CASE EXAMPLEVALVE RELEASE AND ASSESSMENT


Conformable frame, Consistent Radial Force, and External Wrap for Advanced Sealing

EVOLUT PRO CASE: LVOT CALCIFICATIONAR AT DISCHARGE AND 30 DAYS


Site Reported AR*:• Discharge = None• 30 Days = None

Unsurpassed Hemodynamics

▪ *Represents one case only and may not be indicative of clinical performance in other patients.

MEDTRONIC EVOLUT PRO SYSTEMSUMMARY


Intended for Advanced Sealing

▪ Conforming frame and consistent radial force provide contact at multiple levels in various annulus shapes

▪ External tissue wrap increases surface contact area

Proven Platform Performance

▪ Controlled, accurate deployment with the ability to recapture

▪ Supra-annular valve function provides unsurpassed hemodynamics

▪ Lowest delivery profile with integrated InLine Sheath

Thank you for your kind attention!

medtronic evolut pro: system overview pro overview .pdf · bav according to standard practice...

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